Recruiting NCT06956755

Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

— Observational Myelodysplastic Syndromes Leukemia, Myeloid, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia

Detailed description

This registry was created in July 2003 by GFM Group. It is conducted in accordance with the French law on data processing and freedom relating to the processing of personal data in the field of health (law n°78-17 of 6 January 1978 as amended). It has received the favorable opinion of the ethics committee for research and the authorization of the National Commission on Informatics and Freedoms. (CNIL) Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

The registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data. Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

To date, 70 GFM centers participate in this registry, 5300 patients have been included. Approximately 400 to 500 new patients are currently included per year.

Data are recorded and entered through the web-based e-CRF by haematology centers in 70 centers of GFM at inclusion and Follow-up of the patients every six months.

Data analyses are conducted by the SBIM (Medical and Biostatistical Computing at service of Pr Sylvie CHEVRET, Hospital Saint Louis). Data quality control including monitoring of both clinical execution and data collection implemented from the initiation of the Registry has resulted in high quality data.

Registry MDS has included the most patients and has proven itself as a well-established operational, and constantly evolving project in an elderly population.

The registration of new patients is still ongoing, and the follow-up of the project is unlimited.

Primary outcome measures

Hemoglobin level Unit of Measure g/dL [Time frame: At enrollment]
Absolute neutrophil count / Unit of Measure G/L [Time frame: At enrollment]
Platelet count Unit of Measure / Unit of Measure: %G/L [Time frame: At enrollment]
Percentage of bone marrow blasts at enrollment / Unit of Measure: percent [Time frame: At enrollment]
Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients [Time frame: At enrollment]
Cytogenetic abnormalities at enrollment / Unit of Measure percent of patients [Time frame: At enrollment]
IPSS-R risk classification at enrollment / Unit of Measure percent of patients by category [Time frame: At enrollment]
Presence of somatic mutations at enrollment / Unit of Measure: percent of patients [Time frame: At enrollment]
Demographic characteristics at enrollment / Unit of Measure: Descriptive (e.g., mean ± SD for age, % for sex distribution) [Time frame: At enrollment]

Secondary outcome measures (9)

Overall survival [Time frame: From diagnosis until death or last follow-up, up to 120 months]
Progression-free survival [Time frame: From diagnosis until progression, AML transformation, or death, assessed up to 120 months]
Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia) [Time frame: From diagnosis until last follow-up, up to 120 months]
Duration of first-line treatment for MDS [Time frame: From treatment initiation until discontinuation or last follow-up, assessed up to 60 months]
Time to first documented treatment response [Time frame: From treatment start to first response, assessed up to 60 months]
Time to transformation to acute myeloid leukemia (AML) [Time frame: From diagnosis until AML confirmation or last follow-up, up to 120 months]
Time to transfusion dependency [Time frame: From diagnosis to transfusion dependency or last follow-up, up to 120 months]
Cytogenetic and molecular response rates [Time frame: Assessed during follow-up, up to 120 months]
Time to progression on IPSS score [Time frame: From initial classification to IPSS progression or last follow-up, up to 120 months]

Eligibility criteria

Inclusion criteria

Male or female
Age > 18 years
Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia
Able and willing to provide written informed consent

Exclusion criteria

Age <18 years
Patient is unwilling or unable to give consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 1 center

Aspasia Stamatoullas — Rouen

Identifiers

NCT: NCT06956755 · GFM-MDS Registry

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗